Implantable access devices

• US 5,356,381 A
• Filed: 11/24/1993
• Issued: 10/18/1994
• Est. Priority Date: 03/01/1990
• Status: Expired due to Fees

• Current Assignee: James A. Knol, James C. Andrews, William D. Ensminger
• Original Assignee: James A. Knol, James C. Andrews, William D. Ensminger
• Inventors: Ensminger, William D., Knol, James A., Andrews, James C.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/158,042
• Time in Patent Office: 328 Days
• Field of Search: 604/93, 604/181, 604/183, 604/245-249, 604/256, 604/257
• US Class Current: 604/288.03
• CPC Class Codes: A61M 2039/0211 with multiple chambers in a single site
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0633 the seal being a passive seal made of a resilient material with or without an opening
• CPC Class Codes: A61M 2039/064 Slit-valve
• CPC Class Codes: A61M 2039/0666 Flap-valve
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

An access port (10) for implantation adapted for providing repeated access to specific tissue within a patient and communicating with the tissue by an internal implanted catheter (52). The access ports according to this invention incorporate an enlarged entrance orifice (13) with a funnel shaped internal cavity that narrows down to a reduced diameter passageway (18). An articulating catheter valve (24) is provided within the passageway which normally prevents the flow of fluids through the valve but which can be penetrated by an external introduced filament (32) such as a catheter. After implantation, an external filament (32) is introduced into the port (10) and guided by the passageway into registry with the catheter valve (24). Continued feeding of the filament (32) causes the filament to pass through the valve (24). Thereafter, with a catheter (32) inserted, therapeutic agents can be infused into the patient, or body fluids can be withdrawn. Alternate embodiments disclose various valve concepts (56) and means for providing a change in direction of an introduced filament inserted through the access device. Additional embodiments disclose the concepts of providing an antimicrobial fluid bath (98) within the device for prevention of infection and various approaches for securely connecting an internal catheter (52) to an access port.

Claims

1. An implantable access device for permitting the access to a predetermined location within the body of a patient through an implanted internal catheter by a percutaneously placed filament such as a needle, external catheter, wire or optical fiber, said device being implantable within the body of the patient comprising:

a housing having a funnel shaped entrance orifice, a passageway and an exit orifice adapted for communication with the internal catheter, said entrance orifice having a decreasing cross sectional area defining a target area for insertion of said filament and causing said filament introduced into said entrance orifice to be directed to and enter said passageway, said passageway connecting said entrance orifice with said exit orifice,

a valve means positioned within said housing and normally remaining closed for providing resistance to flow of fluids through said passageway, said valve means also permitting passage of said filament therethrough for enabling said filament to pass through said housing and communicate with said predetermined location, and

means for supporting said access device within the body of the patient.

2. An implantable access device according to claim 1 wherein said entrance orifice is conical in shape.

3. An implantable access device as set forth in claim 2 wherein said entrance orifice includes a guide lip extending off of said entrance orifice increasing the size of said target area for insertion of said filament thereinto.

4. An implantable access device according to claim 1 wherein said entrance orifice includes a circular perimeter, said exit orifice being concentric with said circular perimeter.

5. An implantable access device according to claim 1 wherein said entrance orifice includes a circular perimeter, said exit orifice and said passageway being concentric with said circular perimeter.

6. An implantable access device according to claim 1 wherein said passageway and said exit orifice are coaxial.

7. An implantable access device according to claim 1 wherein said entrance orifice includes a perimeter defining a plane generally parallel with skin of said patient overlying said access device upon implantation of said access device within the body of the patient.

8. An implantable access device according to claim 1 wherein said valve means is an articulating valve designed for repeated engagement by said filament at a predetermined location.

9. An implantable access device according to claim 8 wherein said means is positioned within said passageway substantially adjacent to said entrance orifice.

10. An implantable access device according to claim 1 wherein said entrance orifice is formed by a surface of a hard material causing said filament contacting said surface to be directed toward said passageway.

11. An implantable access device according to claim 1 wherein said entrance orifice includes a recessed region defined therein increasing the area of said target area for the insertion of said filament thereinto.

12. An implantable access device according to claim 1 wherein said device comprises two spaced apart valve means defining a reservoir space therebetween.

13. An implantable access device according to claim 1 wherein said entrance orifice has a curved funnel shape.

14. An implantable access device according to claim 1 wherein said entrance orifice includes a guide lip extending off of said entrance orifice increasing said area of said target area for insertion of said filament thereinto.

15. An implantable access device according to claim 1 wherein said housing includes locating means which can be detected through external palpation after implantation of said device for determining the orientation of said entrance orifice.

16. An implantable access device according to claim 15 wherein said locating means is a projection on said housing.

17. An implantable access device according to claim 15 wherein said locating means is a recess in said housing.

18. An implantable access device according to claim 17 wherein said locating means includes recesses permitting external gripping of said device after implantation of said device during insertion of said filament.

19. An implantable access device according to claim 1 wherein said housing further includes portions at least partially defining a cavity for said valve means within said passageway with said valve means being positioned therein.

20. An implantable access device according to claim 19 wherein said device further comprises a plug, said plug engaging said housing and includes a surface cooperating with said housing to define said cavity.

21. An implantable access device according to claim 20 wherein said plug is threadably engaged with said housing.

22. An implantable access device according to claim 20 wherein said plug includes an exit passageway defining said exit orifice.

23. An implantable access device according to claim 22 wherein said plug includes an integrally formed exit tube, said exit passageway being defined therein.

24. An implantable access device according to claim 19 wherein said valve means is an articulating valve positioned within said cavity.

25. An implantable access device according to claim 24 wherein said cavity includes a first conical surface leading from said passageway generally to said valve means and a second conical surface leading from said valve means generally to said exit orifice.

26. An implantable access device according to claim 25 wherein said first conical surface is defined by a first cone angle and said second conical surface is defined by a second cone angle, said first cone angle being larger than said second cone angle.

27. An implantable access device according to claim 1 wherein said valve means is a leaflet valve having at least one generally flat disk of resilient material with at least one cut therethrough defining at least two leaves which are deflected upon insertion of said filament therethrough.

28. An implantable access device according to claim 27 wherein said housing constrains deflection of said leaves thereby inducing greater friction on said filament during withdrawal from said access device as compared with insertion of said filament into said access device.

29. An implantable access device according to claim 19 wherein said cavity is at least partially defined by a surface directing said filament toward said exit orifice.

30. An implantable access device according to claim 29 wherein said surface directing said filament toward said exit orifice is a conical surface.

31. An implantable access device according to claim 1 wherein said device further comprises stop means for limiting insertion of a relatively rigid filament through said device, said stop means permitting a flexible filament being more flexible than said relatively rigid filament to be further inserted through said device.

32. An implantable access device according to claim 31 wherein said stop means is formed in said passageway.

33. An implantable access device according to claim 32 wherein said stop means is a bend in said passageway.

34. An implantable access device according to claim 32 wherein said stop means is generally adjacent to said exit orifice.

35. An implantable access device according to claim 32 wherein said stop means is positioned between said entrance orifice and said valve means.

36. An implantable access device according to claim 1 wherein said housing includes a shield protecting said internal catheter from accidental contact with said filament as said filament is being inserted into the patient.

37. An access device being implantable within the body of a patient at a predetermined position for permitting access to an internal catheter by a flexible filament such as an external catheter, wire or optical fiber comprising:

a housing defining an entrance orifice and an exit orifice adapted for communication with said internal catheter with said entrance orifice having a cross-sectional open area which decreases from said entrance orifice to a passageway communicating with said exit orifice, said entrance orifice causing said filament introduced into said entrance orifice to be directed toward and into said passageway,

at least one articulating valve positioned within said housing which normally remains closed to provide resistance to flow of fluids through said valve, said valve permitting said filament to pass through said valve enabling said filament to pass through said housing and communicate with said internal catheter, said valve assembly further sealing around said filament when said filament is introduced through said valve and

means for supporting said housing in a predetermined position within the body of a patient.

38. An implantable patient access device for permitting access to a predetermined location within the body of a patient through an implanted internal catheter by a percutaneously placed filament such as a needle, external catheter, wire or optical fiber comprising:

a housing defining an entrance and a single exit orifice, adapted for communication with said internal catheter with said entrance orifice having a cross-sectional open area which decreases from said entrance orifice to a passageway communicating with said exit orifice, said entrance orifice causing said filament introduced into said entrance orifice to be directed toward and into said passageway and through said exit orifice,

at least one articulating valve positioned within said housing passageway which normally remains closed to provide resistance to flow of fluids through said valve, yet opens to permit said filament to pass through said valve enabling said filament to communicate with said internal catheter through said exit orifice, and

means for supporting said housing within the body of the patient.

39. A method for permitting repeated percutaneous access by a filament such as a needle, external catheter, wire or optical fiber, to preselected tissue within the body of a patient comprising the steps of:

implanting within the body of the patient an access device having an funnel shaped entrance orifice, a passageway, an exit orifice, and an articulating valve which normally resists the flow of fluids through said passageway while allowing passage of said filament therethrough,

providing an internal catheter and connecting said internal catheter to said access device at said exit orifice and positioning said internal catheter to communicate from the access device to said preselected tissue,

providing said filament,

inserting said filament percutaneously into said access device entrance orifice, and

feeding said filament through said articulating valve and into said internal catheter, thereby providing said filament access to said preselected tissue.

40. A method for permitting repeated access to preselected tissue within the body of a patient by a rigid filament having a less rigid coaxial filament therewith comprising the steps of:

implanting within the body of the patient an access device having an funnel shaped entrance orifice, a passageway, an internal cavity, an exit orifice, an articulating valve which normally resists the flow of fluids through said passageway, and limiting means for limiting the depth to which said rigid filament may be inserted into said device,

providing an internal catheter and connecting said internal catheter to said access device at said exit orifice and positioning said internal catheter to communicate from said access device to said preselected tissue,

providing said rigid and less rigid filaments,

inserting said rigid and less rigid filaments percutaneously into said access device through said entrance orifice,

withdrawing said rigid filament from said access device while retaining said less rigid filament within said access device, and

further inserting said less rigid filament into said access device beyond said limiting means thereby providing access to said preselected tissue.

41. The method according to claim 40 wherein said rigid and less rigid filaments are inserted to a depth limited by said limiting means.

42. The method according to claim 40 wherein said limiting means is positioned between said entrance orifice and said valve.

43. The method according to claim 40 wherein said limiting means is positioned between said valve and said exit orifice.

44. A method for permitting repeated access by a wire to an internal catheter providing access to preselected tissue within the body of a patient, said method comprising the steps of:

providing an implantable access device having a funnel shaped entrance orifice, a passageway, an exit orifice, and an articulating valve which normally resists the flow of fluids through said access device yet permits passage of said wire therethrough,

providing an internal catheter and connecting said internal catheter to said access device at said exit orifice and positioning said internal catheter to communicate from said access device to said preselected tissue,

providing said wire,

inserting said wire percutaneously into and through said access device, and

manipulating said wire to perform an intended function of said wire.

45. The method of claim 44 wherein said wire is a clearing wire and further comprising the steps of:

feeding said clearing wire through said valve and into said internal catheter, and

manipulating said clearing wire to clear said internal catheter of accumulated deposits therein.

46. A method for permitting access by a guide wire to an internal catheter providing access to a preselected tissue within the body of a patient, said method comprising the steps of:

providing an implantable access device having an funnel shaped entrance orifice, a passageway, an exit orifice, and an articulating valve which normally resists the flow of fluids through said access device yet which permits passage of said guide wire therethrough,

providing an internal catheter connected to said access device at said exit orifice and positioning said internal catheter to communicate from said access device to said preselected tissue,

providing said guide wire,

inserting said guide wire percutaneously into said access device through said entrance orifice,

feeding said guide wire through said access device and into said internal catheter, and

manipulating said guide wire to steer said guide wire within the body of the patient.

47. A method for locating an entrance to an access device implanted within the body of a patient and permitting repeated access to a preselected tissue within said patient by a filament such as a needle, external catheter, wire or optical fiber, said method comprising the steps of:

providing said implanted access device having a funnel shaped entrance orifice, indicia being provided on said device in a predetermined relation to said entrance orifice, said indicia indicating the orientation and position of said entrance orifice and being detectable through palpation, said access device further having a passageway, an exit orifice, and an articulating valve which normally resists the flow of fluids through said access device yet permits passage of said filament therethrough,

providing an internal catheter and connecting said internal catheter to said access device at said exit orifice and positioning said internal catheter to communicate from said access device to said preselected tissue,

performing palpation of said access device externally of said patient to locate said indicia,

utilizing said indicia to determine the orientation and position of said entrance orifice relative to said patient,

inserting said filament percutaneously into said entrance orifice, and

feeding said filament through said access device and into said internal catheter thereby providing access to said preselected tissue.

48. An access device being implantable within the body of a patient for permitting access to an internal catheter by a filament such as a needle, external catheter, wire or optical fiber comprising:

a housing including a funnel shaped entrance orifice having a perimeter defining a target area for insertion of said filament, said housing also including an exit orifice and a passageway communicating said entrance orifice with said exit orifice, said entrance orifice having a decreasing cross-sectional area causing said filament introduced into said entrance orifice to be directed to and enter said passageway, said passageway being angularly oriented with respect to a normal line through a plane defined by said perimeter thereby causing said filament to undergo a bend,

a barrier positioned within said housing and to provide resistance to flow of fluids through said device, said barrier permitting passage of said filament therethrough enabling said filament to communicate with said internal catheter, and

a base configured for supporting said access device in a predetermined position within said body of said patient.

49. An implantable access device for permitting access to an internal catheter by a filament such as a needle, external catheter, wire or optical fiber, said device being implantable beneath the skin and within the body of a patient, said access device comprising:

a housing including a funnel shaped entrance orifice, a passageway and an exit orifice, said entrance orifice having a decreasing cross-sectional area defining a target area for insertion of said filament and causing said filament introduced into said entrance orifice to be directed to and enter said passageway, said passageway connecting said entrance orifice with said exit orifice;

a leaflet valve positioned within said passageway and normally remaining closed for providing resistance to flow of fluids through said passageway, said leaflet valve also permitting passage of said filament therethrough for enabling said filament to pass through said housing and communicate with said internal catheter, said leaflet valve including at least two resilient disks each having at least one slit formed therein, said slits of each of said disks being disaligned with one another; and

means for supporting said access device in a predetermined position within said body of said patient.

50. An access port being implantable within the body of a patient for permitting access to an internal catheter by the percutaneous introduction of an external filament such as a catheter, needle, guide wire or optical fiber, said access device comprising:

a housing defining a funnel shaped entrance orifice and a single exit orifice, said entrance orifice having a cross-sectional open area which decreases in size to a passageway communicating with said exit orifice, said housing causing said filament introduced into said entrance orifice to be directed to enter said passageway,

a leaflet valve assembly within said passageway and having at least one disk of resilient material, at least one slit through said disk defining two or more deflectable valve leaves, said valve assembly normally remaining closed to provide resistance to the flow of fluids through said valve assembly, said valve assembly opening to permit passage of said external filament inserted through said passageway and enabling said filament to pass through said housing and communicate with said internal catheter, and

a support surface formed by said housing for enabling said housing to be supported within said body of said patient.